RESUMEN
Like the "nurse practitioner" in Anglo-Saxon countries, the French health authority validated on January 2016 the creation of an intermediate grade called advanced practice nurse (APN). They are authorized to carry out an assessment of the person's state of health, through a complete clinical examination. They can also prescribe additional examinations necessary for the monitoring of the pathology, and carry out certain acts for diagnostic and/or therapeutic purposes. Given the specificities of cellular therapy patients, the content of university professional training doesn't seem sufficient to assure an optimal management by the APN of these patients. The Francophone society of bone marrow transplantation and cellular therapy (SFGM-TC) had already published two works regarding what was initially called "the transfer of skills" between doctors and nurses in the follow-up of transplant patients. In the same way, this workshop attempts to address the question of the place of APNs in the management of patients undergoing cellular therapy treatment. Beyond a delegation of tasks as proposed by the cooperation protocols, this workshop produces recommendations to allow an autonomous activity of the IPA in the follow-up of these patients, in close collaboration with the medical team.
Asunto(s)
Trasplante de Médula Ósea , Trasplante de Células Madre Hematopoyéticas , Humanos , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Sociedades Médicas , Tratamiento Basado en Trasplante de Células y TejidosRESUMEN
Tisagenlecleucel (Kymriah™) and axicabtagene ciloleucel (Yescarta™) are the first two approved drug products that belong to of a new class of therapies manufactured through an industrial process that includes the ex vivo genetic modification of human autologous T lymphocytes with viral vectors. Since CAR-T Cells qualify as gene therapy medicinal products, there is a requirement for long-term (15 years) follow-up of treated patients. As part of a global initiative aiming at a better use of continental registries to study the outcome of homogeneous groups of patients, EMA issued a positive opinion on the use of the EBMT registry to capture LTFU of patients treated with CAR-T Cell in EU Member states. The use of a European registry will provide a global view of this new field across EU countries and across diverse indications, and bears advantages over the use of registries dedicated to specific categories of diseases, or national registries. This is an important asset to fully measure the medical value of these innovative therapies in real-life conditions, and assess whether pricing is fully justified. To fulfill EMA requirements, as well as requirements from Pharma companies, EBMT has designed a new Cellular Therapy Med-A form that allows to capture the essential information on the administered drug product, disease and patient. Registering patients and capturing follow-up data is already possible in Promise, and will be made easier when the full migration of the EBMT database from Promise to MACRO is completed in the forthcoming weeks. Negotiations are ongoing with all interested parties including patients to define in which conditions data will be accessed and analyzed; the underlying principle is to favor rather than restrict the use of data, with a view to build cooperative projects involving relevant cooperative groups and professional associations. Here, we present practical recommendations issued by SFGM-TC to help data managers capture information related to patients treated with CAR-T Cells.